Fibrostenotic Eosinophilic Esophagitis: Assessment Tools

NCT ID: NCT02453126

Last Updated: 2024-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2024-06-30

Brief Summary

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This protocol addresses a central hypothesis that fibrostenotic Eosinophilic Esophagitis (EoE) is characterized by abnormal esophageal structure and compliance compared to non fibrostenotic EoE and that distinctive cellular and molecular profiles predict the fibrostenotic phenotype. This study aims to define and assess the changes that occur in the structure and dynamics of the esophageal wall in pediatric Eosinophilic Esophagitis along with characterizing the histologic and molecular patterns in fibrostenotic EoE.

Detailed Description

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Conditions

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Eosinophilic Esophagitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Scheduled to undergo a clinical upper endoscopy with biopsy

Exclusion Criteria

* Known connective tissue disorder
* Increased risk of bleeding
* Inflammatory bowel disease, celiac disease, eosinophilic gastroenteritis, or any autoimmune disease
* Other esophageal disease including known achalasia; history of caustic ingestion, esophageal surgery esophageal stricture for other known reason or other esophageal injury.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Calies Menard-Katcher, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado/Childrens Hospital Colorado

Locations

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Children's Hospital Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cassandra Burger

Role: CONTACT

720-777-5739

Facility Contacts

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Cassandra Burger

Role: primary

720-777-5739

Other Identifiers

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UL1TR001082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-0594

Identifier Type: -

Identifier Source: org_study_id

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